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Avion Pharmaceuticals Announces FDA Approval of Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) Oral Contraceptive
ATLANTA, Jan. 17, 2018 /PRNewswire/ -- Avion Pharmaceuticals, LLC, the makers of the Prenate ® line of prescription prenatal vitamins, received approval of its new drug application (NDA) for the oral contraceptive Balcoltra (levonorgestrel and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 17, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC
Ridgefield, Conn., January 16, 2018 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib) for the first-line treatment of patients... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 16, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer
January 12, 2018 -- The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 12, 2018 Category: Drugs & Pharmacology Source Type: news

GSK Receives FDA Approval for Expanded Indication for Fluarix Quadrivalent (Influenza Vaccine) for Persons 6 Months and Older
Philadelphia, PA, January 11, 2018 -- GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration ’s (FDA) Center for Biologics Evaluation and Research expanding the indication for Fluarix Quadrivalent... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 11, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma
THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to expand the currently... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 5, 2018 Category: Drugs & Pharmacology Source Type: news

Bausch + Lomb Receives FDA Approval of Lumify (brimonidine tartrate) Over-the-Counter Eye Drop for the Treatment of Eye Redness
LAVAL, Quebec, Dec. 22, 2017 /PRNewswire/ -- Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ( " Valeant " ), today announced that the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Segluromet (ertugliflozin and metformin hydrochloride) for Type 2 Diabetes
KENILWORTH, N.J.& NEW YORK--(BUSINESS WIRE) December 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Steglujan (ertugliflozin and sitagliptin) for Type 2 Diabetes
KENILWORTH, N.J.& NEW YORK--(BUSINESS WIRE) December 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Steglatro (ertugliflozin) for Type 2 Diabetes
KENILWORTH, N.J.& NEW YORK--(BUSINESS WIRE) December 22, 2017 -- Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response
December 22, 2017 -- The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Giapreza (angiotensin II) to Treat Dangerously Low Blood Pressure
December 21, 2017 -- The U.S. Food and Drug Administration today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. " Shock, the inability to maintain... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2017 Category: Drugs & Pharmacology Source Type: news

Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency
CHARLESTON, S.C. December 20, 2017 -- Aeterna Zentaris Inc. (NASDAQ and TSX: AEZS), a specialty biopharmaceutical company engaged in developing and commercializing pharmaceutical therapies, announced today that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 20, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer
South San Francisco, CA -- December 20, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Perjeta ® (pertuzumab), in combination with Herceptin®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 20, 2017 Category: Drugs & Pharmacology Source Type: news

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease
PRINCETON, N.J.--(BUSINESS WIRE)-- December 20, 2017 Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 20, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Pfizer ’s Bosulif (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)
December 19, 2017 -- Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 19, 2017 Category: Drugs & Pharmacology Source Type: news

Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Untreated Advanced Renal Cell Carcinoma
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 19, 2017-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved Cabometyx (cabozantinib) tablets for the expanded indication of patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 19, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Luxturna (voretigene neparvovec-rzyl) Gene Therapy to Treat Patients with a Rare Form of Inherited Vision Loss
December 19, 2017 -- The U.S. Food and Drug Administration today approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 19, 2017 Category: Drugs & Pharmacology Source Type: news

Aerie Pharmaceuticals Announces U.S. FDA Approval of Rhopressa (netarsudil ophthalmic solution) 0.02% for Patients with Open-Angle Glaucoma or Ocular Hypertension
IRVINE, Calif.--(BUSINESS WIRE)--Dec. 18, 2017-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), an ophthalmic pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 19, 2017 Category: Drugs & Pharmacology Source Type: news

Medicure Announces FDA Approval Received for Prexxartan (valsartan) Oral Solution
WINNIPEG, Dec. 19, 2017 /PRNewswire/ - Medicure Inc. ( " Medicure " or the " Company " ) (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, today announced that Carmel Biosciences, Inc. ( " Carmel " ) has received final approval of its New Drug Application from... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 19, 2017 Category: Drugs & Pharmacology Source Type: news

Aclaris Therapeutics Receives FDA Approval for Eskata (hydrogen peroxide) Topical Solution, 40% (w/w) for the Treatment of Raised Seborrheic Keratoses
MALVERN, Pa., Dec. 15, 2017 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Eskata (hydrogen peroxide) topical... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 17, 2017 Category: Drugs & Pharmacology Source Type: news

Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream 1%, a Novel Topical Antibiotic for Impetigo
FAIRFIELD, N.J., Dec. 14, 2017 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Xepi (ozenoxacin) Cream, 1%, a new chemical entity for the treatment of impetigo in patients... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 14, 2017 Category: Drugs & Pharmacology Source Type: news

Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream, 1%, a Novel Topical Antibiotic for Impetigo
FAIRFIELD, N.J., Dec. 14, 2017 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Xepi (ozenoxacin) Cream, 1%, a new chemical entity for the treatment of impetigo in patients... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 14, 2017 Category: Drugs & Pharmacology Source Type: news

Pfizer Announces FDA Approval of Xeljanz (tofacitinib) and Xeljanz XR for the Treatment of Active Psoriatic Arthritis
December 14, 2017 - Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 14, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ixifi (infliximab-qbtx), a Biosimilar to Remicade
December 13, 2017 -- Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Ixifi (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 13, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Nucala (mepolizumab) for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)
December 12, 2017 -- The U.S. Food and Drug Administration today expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 12, 2017 Category: Drugs & Pharmacology Source Type: news

Omeros Corporation Announces FDA Approval of Omidria for Use in Pediatric Patients
SEATTLE--(BUSINESS WIRE)--Dec. 12, 2017-- Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 12, 2017 Category: Drugs & Pharmacology Source Type: news

Intersect ENT Announces FDA Approval of Sinuva (mometasone furoate) Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps
MENLO PARK, Calif.--(BUSINESS WIRE)--Dec. 11, 2017-- Intersect ENT, Inc. (NASDAQ: XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced that it has received approval from the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 11, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Admelog (insulin lispro) Rapid-Acting " Follow-On " Insulin Product to Treat Diabetes
December 11, 2017 -- The U.S. Food and Drug Administration today approved Admelog (insulin lispro injection), a rapid-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 11, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Admelog (insulin lispro) Short-Acting " Follow-On " Insulin Product to Treat Diabetes
December 11, 2017 -- The U.S. Food and Drug Administration today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 11, 2017 Category: Drugs & Pharmacology Source Type: news

Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
December 5, 2017 -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Ozempic (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 5, 2017 Category: Drugs & Pharmacology Source Type: news

Sunovion Receives FDA Approval for Lonhala Magnair (glycopyrrolate) Inhalation Solution to Treat COPD
MARLBOROUGH, Mass.--(BUSINESS WIRE) December 5, 2017 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala Magnair (glycopyrrolate) Inhalation... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 5, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin
December 1, 2017 -- The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2017 Category: Drugs & Pharmacology Source Type: news

Dr. Reddy ’s Announces Approval of Impoyz (clobetasol propionate) Cream for Plaque Psoriasis
HYDERABAD, India& PRINCETON, N.J.& MALVERN, Pa.--(BUSINESS WIRE) December 01, 2017 --Dr. Reddy ’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), through its wholly owned subsidiary Promius Pharma, LLC, today announced its fifth... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2017 Category: Drugs & Pharmacology Source Type: news

Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis
INDIANAPOLIS, Dec. 1, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Amgen's Repatha (evolocumab) to Prevent Heart Attack and Stroke
THOUSAND OAKS, Calif., Dec. 1, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha (evolocumab) as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sublocade (buprenorphine) Once-Monthly Injection for Opioid Use Disorder
November 30, 2017 -- The U.S. Food and Drug Administration today approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 30, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep
Parsippany, NJ – November 29, 2017 – The U.S. Food and Drug Administration (FDA) has granted Ferring Pharmaceuticals Inc. approval to market Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution for cleansing of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 29, 2017 Category: Drugs & Pharmacology Source Type: news

Merck Receives FDA Approval for Isentress (raltegravir), in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Newborns Weighing at Least 2 kg
KENILWORTH, N.J. November 29, 2017 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Isentress (raltegravir), the company’s integrase inhibitor,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 29, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Juluca (dolutegravir and rilpivirine) for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection
November 21, 2017 -- The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 21, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kal éo’s Auvi-Q (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children
Richmond, VA (November 20, 2017) kal éo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Auvi-Q (epinephrine injection, USP) 0.1... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 20, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sutent (sunitinib malate) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma
November 16, 2017 -- The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors
November 16, 2017 -- The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Gazyva for Previously Untreated Advanced Follicular Lymphoma
South San Francisco, CA -- November 16, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) in combination with chemotherapy,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 16, 2017 Category: Drugs & Pharmacology Source Type: news

Noden Pharma Announces FDA Approval of Tekturna (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older
DUBLIN, Nov. 15, 2017 /PRNewswire/ -- Noden Pharma DAC, a global specialty pharmaceutical company that is focused on acquiring prescription medicines across a broad range of therapeutic areas, announced today the approval by the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 15, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Mepsevii (vestronidase alfa) for Mucopolysaccharidosis Type VII
November 15, 2017 -- The U.S. Food and Drug Administration today approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 15, 2017 Category: Drugs & Pharmacology Source Type: news

Faslodex (fulvestrant) Receives FDA Approval for the Treatment of Advanced Breast Cancer in Combination with Abemaciclib
15 November 2017 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication for Faslodex (fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 15, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fasenra (benralizumab) for Severe Eosinophilic Asthma
November 14, 2017 -- AstraZeneca (NYSE:AZN) and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 14, 2017 Category: Drugs & Pharmacology Source Type: news

Allergan Receives FDA Approval for Vraylar (cariprazine) in the Maintenance Treatment of Schizophrenia
DUBLIN, Nov. 13, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the maintenance treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 13, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Approves Abilify MyCite (aripiprazole) Pill with Sensor to Digitally Track if Patients Have Ingested Their Medication
November 13, 2017 -- The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 13, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Expands Approval of Sprycel (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
PRINCETON, N.J.--(BUSINESS WIRE) November 10, 2017 --Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of children... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 10, 2017 Category: Drugs & Pharmacology Source Type: news